t900607 in treating patients with gastroesophageal junction cancer

Conditions: Gastric Cancer

Summary: rationale: drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of t900607 in treating patients who have gastroesophageal junction cancer.

objectives: * determine the response rate (complete and partial) in patients with previously treated gastric or gastroesophageal junction carcinoma treated with t900607. (gastric carcinoma closed to accrual as of 02/04.) * determine the duration of response and time to disease progression in patients treated with this drug. * determine the pharmacokinetics of this drug in these patients. * determine the safety profile of this drug in these patients. outline: this is an open-label, multicenter study. patients receive t900607 iv over 1 hour once weekly. treatment continues in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 20-35 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed gastric or gastroesophageal junction carcinoma (gastric carcinoma closed to accrual as of 02/04) * must have received 1 or 2 prior chemotherapy regimens for gastric carcinoma (gastric carcinoma closed to accrual as of 02/04) * bidimensionally measurable disease * at least 1 lesion that is at least 10 mm by ct scan * no cns metastases or carcinomatous meningitis patient characteristics: age * 18 and over performance status * karnofsky 70-100% life expectancy * at least 12 weeks hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3\* * platelet count ≥ 100,000/mm\^3\* * hemoglobin ≥ 8.5 g/dl\* note: \*independent of growth factor or transfusion support hepatic * bilirubin ≤ 1.5 times upper limit of normal (uln) * ast and alt ≤ 3 times uln * inr ≤ 1.5 (unless receiving anticoagulants) * albumin \> 2.5 g/dl renal * creatinine ≤ 2 times uln cardiovascular * no new york heart association class iii or iv heart disease * lvef ≥ 50% * no acute anginal symptoms other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after study participation * able to comply with study procedures and follow-up * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * no severe infection * no other concurrent severe medical condition or comorbidity that would preclude study participation prior concurrent therapy: biologic therapy * more than 7 days since prior growth factors or blood transfusions * no concurrent therapeutic biological response modifier therapy * no concurrent immunotherapy chemotherapy * see disease characteristics * no other concurrent cytotoxic chemotherapy endocrine therapy * no concurrent hormonal therapy radiotherapy * no concurrent radiotherapy (including palliative radiotherapy) surgery * more than 4 weeks since prior major surgery other * more than 4 weeks since prior investigational agents * no other concurrent investigational anticancer therapy

Keywords: recurrent gastric cancer